Swiss pharmaceutical company Novartis (NVS) reported that a late-stage trial of its meningococcal disease vaccine Menveo in infants met its primary endpoints. The results show Menveo could offer protection against meningitis -- an infection of the brain and spinal cord. Now, the drugmaker intends to file Menveo for use in infants in the U.S. and Europe.

The Phase III study included 4,545 healthy infants in the U.S. and Latin America. The results, from the U.S. sites only, show that a high percentage (between 94% and 100%) of infants vaccinated with four doses at 2, 4, 6 and 12 months of age achieved robust immune responses against four meningococcal strains -- A, C, Y and W-135. Menveo was generally well tolerated, Novartis added, with similar safety profile to other infant vaccines.

Infants Are at the Greatest Risk

Meningococcal disease is a sudden, unpredictable, serious and often deadly disease. It is a leading cause of bacterial meningitis -- an infection of the membrane around the brain and spine -- and sepsis -- a bloodstream infection. Infants under one year old are at greatest risk because the highest rates occur early in the first year of life. Up to 10% of children in that age group who contract meningococcal disease die. Currently, no broad-coverage vaccine is licensed for infants.

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"In my practice, I have seen the devastating effects of meningococcal disease in infants," said Dr. Stan Block, an investigator for the study. "Meningococcal vaccines are being developed that can provide broad protection against the disease in this vulnerable population."

Based on the study, Novartis now plans to file for an application of a broader use of the vaccine with the U.S. Food and Drug Administration by year-end. Menveo is approved in the U.S. for use in those 11 to 55 years old. The FDA is also currently reviewing Menveo for children 2 to 10 years old.

Globally, more than 500,000 cases of meningococcal disease occur each year, leading to more than 50,000 deaths.